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34 1.6 Stability Workshop ICH Q1F C - IKEV

ICHQ1F C ICH Q1F Guideline Stability Data Package for Registration in Climatic Zones III and IV Step 4 in the ICH process Comments for its application ICHQ1F C 60 1. General Consideration Definition and storage conditions for the four climatic zones Climatic zone Definition Storage condition I II III IV temperate climate subtropical and Mediterranean climates hot, dry climate hot, humid climate 21 C/45% 25 C/60% 30 C/35% 30 C/70% 1. General Consideration Criteria used to classify a site according to climatic zone Criteria Guidevalues for individual climatic zone I II III IV Mean annual temperature measured in the open air Calculated mean annual Temperature (< 19 C) Mean annual water Vapour partial pressure

ICHQ1F C 59 1.6 ICH Q1F Guideline Stability Data Package for Registration in Climatic Zones III and IV Step 4 in the ICH process Comments for its application

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Transcription of 34 1.6 Stability Workshop ICH Q1F C - IKEV

1 ICHQ1F C ICH Q1F Guideline Stability Data Package for Registration in Climatic Zones III and IV Step 4 in the ICH process Comments for its application ICHQ1F C 60 1. General Consideration Definition and storage conditions for the four climatic zones Climatic zone Definition Storage condition I II III IV temperate climate subtropical and Mediterranean climates hot, dry climate hot, humid climate 21 C/45% 25 C/60% 30 C/35% 30 C/70% 1. General Consideration Criteria used to classify a site according to climatic zone Criteria Guidevalues for individual climatic zone I II III IV Mean annual temperature measured in the open air Calculated mean annual Temperature (< 19 C)

2 Mean annual water Vapour partial pressure up to 15 C up to C up to 11 mbar > 15 22 C > 24 C > 11 18 mbar > 22 C > 24 up to 15 mbar > 22 C > 24 > 15 mbar ICHQ1F C 61 Countries assigned to the climatic zones III and IV (4): America: Barbados, Belize, Brazil, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Guyana, Haiti, Honduras, Jamaica, Columbia, Cuba, Nicaragua, Dutch Antilles, Panama, Paraguay, Puerto Rico, Venezuela. All these countries are assigned to CZ IV. Africa: Angola, Ethiopia, Benin, Botswana (111), Burkino Faso, Burundi, Djibouti, Ivory Coast, Gabon, Gambia, Ghana, Guinea, Cameroon, Kenya, Longo, Liberia, Madagascar, Malawi, Mali, Mauritania, Mozambique, Niger, Nigeria, Senegal, Sierra Leone, Somalia, Sudan, Tanzania, Togo, Chad (111), Uganda, Zaire, Central African Republic Asia.

3 Bahrain, Bangladesh, Hong Kong, India, Indonesia, Iraq (111), Jordan (111), Kampuchea, Qatar, Kuwait, Laos, Malaysia, Maldives Islands, Myanmar, Oman, Pakistan, Philippines, Saudi Arabia, Singapore, Sri Lanka, Taiwan, Thailand, United Arab Emirates, Vietnam, Yemen Australian/ Fiji, Society Islands, Marshall Islands, New Caledonia, Papua - New Guinea, Oceanic: Samoan, Tonga Storage conditions for countries of III and IV The climatic conditions in a series of cities of the climatic zones III and IV have been, investigated. Thereby measured data (in the open) and calculated data were contrasted (5).

4 For these countries the storage conditions have to be derived. ICHQ1F C 62 Cities of climatic zone III City measured data calculated data temp. [ C ] partial pressure [ mbar ] temp 19 C used [ C ] rel. humidity [ % ] mean kinetictemp. [ C ] days per annum with temp. above 30 C days per annum with 40 C Aswan Baghdad Elat Khartoum Mossul New Delhi Riyadh Suez Jerusalem 20 15 30 40 20 30 15 15 30 20 15 5 15 10 5 20 0 0 mean 24 10 ICHQ1F C 63 Cities of climatic zone IV measured data calculated data derived data City Temp.

5 [ C ] partial pressure [ mbar ] temp. 19 C used [ C ] re. humidity [% ] mean kinetic temp. [ C ] Temp. 30 C [ C ] calculatedre. humidity [% ] Bangkok Belem Bombay Calcutta Darwin Jakarta Karachi Manila Madras Maracaibu Recife Singapore 30 30 30 30 30 30 30 30 30 30 30 30 mean 30 The following information has to be given concerning the two tables Measured data: These data were measured in the open and represent the mean for a year.

6 Calculated data: Drug products are stored in warehouses which may be tempered during the cold season. Therefore 19 C is set in for all temperatures below 19 C. For the corresponding calculated mean temperature the relative humidity is determined. ICHQ1F C 64 Storage conditions for countries of III and IV Mean kinetic temperature: If a mean temperature is calculated and the difference between two temperatures is > 5 C the mean kinetic temperature should be calculated instead of the arithmetic mean temperature. This derives from the fact that the temperature dependency is not linear but Iogarithmic according to the Arrhenius equation.

7 Haynes (7) has derived an equation based on the Arrhenius equation to calculate the Tmkt, the mean kinetic temperature: Tmkt = E/R -ln e- E/RT1 + e- E/RT2 + e- E/RTn n E: activation energy in kJ mol-1 for which 83 kJ mol-1 can be set in (5). Example: 20 C, 40 C: arithmetic mean temperature: 30 C mean kinetic temperature: C The calculated mean kinetic temperatures are C and C. 30 C was therefore fixed as the storage temperature for both, to include a margin of safety of resp. C. The measured, calculated and derived data for climatic zones III and IV are summarized in the following tables 5 and 6.

8 Measured, calculated and derived data Climatic zone measured data calculated data derived data Temp. Partial Pressure [ mbar] Mean kinetic Temp. [ C ] rel. humidity [ % ] Temp. [ C ] rel. humidity [ % ] lll 30 35 lV 30 70 ICHQ1F C 65 Storage conditions and margin of safety Climatic zone Calculated storage condition Derived storage condition Margin of safety [ C ] [ mbar ] [ C ] [%] [ mbar ] [ C ] [ mbar ]

9 II 25 60 III 30 35 IV 30 70 IV* 30 65 * the new storage condition for climatic zone IV Measured and calculated data in warehouses Climatic zone Cities with warehouses measured data in warehouses calculated data for cities with for climatic warehouses zone [ C ] [ % ] [ C ] [ % ] [ C ] [ % ]lll New Delhi, Khartoum 26 35 lV Abidjan, Bangkok, Bombay Colombo, Dacca, Madras Rio de Janeiro, Signapure Conclusions: Measured data in warehouses are in line with calculated data for these cities Applied procedure to calculate data has been proved by the data in warehouses The derived storage conditions are well above the measured data in warehouses and the calculated mean data for climatic zones III and IV.

10 ICHQ1F C 66 ICH Q1F 1. Introduction Objectives of the Guideline Application of ICH Q1A(R) in countries of Climatic zones III and IV Background Long term storage condition is different from 25 C/60% Harmonization with WHO guideline for world wide marketing Scope of the Guideline Annex to Q1A(R2) to market drug substances and drug products in Climatic Zone III and IV 2. guidelines Continuity with the Parent Guideline Parent guideline and published annexes should be followed Following sections are not reproduced - Stress testing - Selection of batches - Container closure system - Specifications - Testing frequency - Statements/labeling - Refrigerated storage - Freezer storage - Semi-permeable or impermeable containers 2.


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